Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Intervention feasibility: accrual rate |
We will assess the number of eligibly-screened caregivers who choose to consent and enroll in the trial. This accrual outcome speaks to intervention feasibility. |
baseline |
|
| Other |
Intervention feasibility: attendance rate |
We will assess the total number of sessions that participants allocated to TACTICs attend (i.e., out of 6 sessions possible). This attendance outcome speaks to intervention feasibility. |
post-intervention |
|
| Other |
Intervention feasibility: retention rate |
We will assess the number of enrolled subjects completing the final outcome assessment at 6 months post-intervention. This retention outcome speaks to intervention feasibility. |
6 months post-intervention |
|
| Other |
Intervention acceptability |
We will assess intervention acceptability using a brief investigator-created battery of quantitative and qualitative satisfaction items. |
post-intervention |
|
| Other |
Health care and resource utilization |
Health care and resource utilization will be measured using an investigator-created battery of items. Items will assess caregiver-reported health and mental care utilization (e.g., ED, inpatient, outpatient) and services accessed or used to support their caregiving (e.g., support groups, respite care, in-home aid). |
baseline, post-intervention, 3 months post-intervention, 6 months post-intervention |
|
| Primary |
Change in Baseline Anxiety via Generalized Anxiety Disorder scale-7 (GAD-7) |
Changes in anxiety will be measured using the Generalized Anxiety Disorder Scale (GAD-7), which contains 7 items with total scores ranging from 0 to 21. Scores of 5, 10, and 15 are cut-offs for mild, moderate, and severe anxiety, respectively. An add-on item assessing the patient's global impression of symptom-related impairment helps researchers understand the extent to which anxiety interferes in daily life. The GAD-7 has factorial validity for the diagnosis of general anxiety disorder and is sensitive to change. |
baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention |
|
| Secondary |
Change in Baseline Depressive Symptoms via Patient Health Questionnaire-9 (PHQ-9) |
Changes in depressive symptoms will be measured using the 9-item Patient Health Questionnaire-9 (PHQ-9) to assess depressive symptoms. With total scores ranging from 0 to 27, scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively. The PHQ-9 has factorial validity for the diagnosis of major depressive disorder. |
baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention |
|
| Secondary |
Change in Baseline Caregiver Burden via Zarit Burden Interview (ZBI) |
Changes in caregiver burden will be measured using the Zarit Burden Interview (ZBI). This two-factor, 22-item scale measures personal strain and role strain in caregiving by summing responses to a total score (0-20 little or no burden; 21-40 mild to moderate burden; 41-60 moderate to severe burden; and 61-88 severe burden). The ZBI measures change over time resulting from the progression of the patient's symptoms or from interventions aimed at reducing burden. |
baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention |
|
| Secondary |
Change in Baseline Wellbeing via Experience of Suffering Scale (ESS) |
Changes in wellbeing will be measured using the Experience of Suffering Scale (ESS). With prior testing in ADRD caregivers, the ESS contains 33 items across 3 subscales: physical (9 items), psychological (15 items), and existential (9 items) suffering. Total scores for each subscale are calculated with higher scores indicating more suffering within each domain. |
baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention |
|
| Secondary |
Change in Baseline Coping via Brief COPE |
Changes in coping will be measured with the 28-item Brief COPE, a measure of coping strategies used in response to stressors. Comprised of 28 coping strategies, the Brief COPE contains 14 two-item subscales, each analyzed separately: self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, venting, behavioral disengagement, positive reframing, planning, humor, acceptance, religion, and self-blame. |
baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention |
|
| Secondary |
Change in Baseline Psychological Flexibility via Acceptance and Action Questionnaire-II (AAQ-II) |
Changes in psychological flexibility and its opposite, experiential avoidance, will be measured using the 7-item Acceptance and Action Questionnaire-II (AAQ-II). Respondents rate how true each statement (e.g., "It is okay if I remember something unpleasant") is for them on a 7-point Likert-type scale anchored from 1=never true to 7=always true. Higher scores indicate greater psychological flexibility or acceptance. |
baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention |
|
| Secondary |
Change in Baseline Quality of Life via PROMIS Global Health measure |
Changes in quality of life will be assessed with the 10-item PROMIS Global Health measure. On a 5-point scale, participants rate their mental and physical well-being with higher scores indicative of better health. |
baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention |
|
| Secondary |
Change in Baseline Anticipatory Grief via Anticipatory Grief Scale (AGS) |
Changes in anticipatory grief will be measured with the Anticipatory Grief Scale (AGS), a 27-item self-report tool designed to assess the bereavement experience of dementia caregivers. Items are scored on a 5-point Likert scale with responses ranging from "strongly disagree" to "strongly agree." |
baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention |
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